Mobirise alternative


Graduate Certificate in
PHARMACEUTICAL REGULATION 

Course Objective: 
Through this Graduate Certificate Programme, we aim to equip working professionals like yourself with updated scientific and regulatory knowledge and critical skills through application-based learning. The skillsets gained through this programme will help you assume diverse roles requiring regulatory science expertise within the public and private sectors.  

An enhanced understanding of regulatory issues will better prepare you to facilitate innovation and pharmaceuticals development as well as provide a deeper appreciation of the basis of regulatory requirements, contributing to timely research and marketing authorisation decisions to support the healthcare systems.

Guided by the Duke-NUS and CoRE education philosophy, the programme aims not only to impart knowledge and understanding but also to facilitate significant networking amongst regulators, industry and other stakeholders. 


Who May Apply: 
Holders of undergraduate Bachelor's degree or its equivalent in relevant discipline. Relevant work experience (i.e., in the fields of regulatory, healthcare or research) at the time of matriculation into Duke-NUS Medical School is desirable.


Powered by Global Thought Leaders: 
Learn from key opinion leaders from national regulatory authorities, noted companies, government agencies and industry associations.


How Many Modules To Complete: 
Select 4 out of 8 modules


Candidature Period and Duration 
As the module credits are valid for a period of five years, it will provide the necessary flexibility for planning your schedule to complete this course, based on your work commitment. 


Curriculum 
The flexible curriculum is designed to accommodate your busy work schedule. The programme is taught through a blended learning approach, engaging students through an online learning management system that delivers content, enables student assessments, and allows for interaction between students. Each module will also feature a 5-day face-to- face workshop.


Assessment Mode 
Activities during the course will be graded to fulfil academic requirements. Each course module will include formal and informal assessments guided by the Duke-NUS teaching pedagogy. You will be graded on individual and group tests as well as group presentations during class discussions. 



Note: Students can take individual modules without registering for the Graduate Certificate. The credits earned can be considered to the Graduate Certificate.

To view full module descriptions, visit https://goo.gl/LW9qG8 

Module Code
GMS5011 (Required module)
Pre-market processes (Choose 1 module)
GMS5012
GMS5101 
Post-market activities (Choose 1 module)
GMS5111
GMS5112 
Regulatory Trends (Choose 1 module) 
GMS5103
GMS5104
GMS5105 

Module Title
Fundamentals of Pharmaceutical Regulation

Chemistry, Manufacturing and Controls
Clinical Trial Design and Data Analysis 

Pharmacovigilance: Principles and Frameworks
Pharmacovigilance: Risk Management Planning 

Regulation of Cell, Tissue and Gene Therapies
Biotherapeutics and Biosimilars
Generic Medicines 

Data Analytics Begins With Me

Brochure

Download in pdf

Per Module Fees

International 
Participant

Singapore Citizen
39
years old or younger
Singapore Citizen
40 years or older1
Singapore
Citizen Eligible
for WTS2
Singapore PRs ≥
21 years older
Enhanced Training
Support for SMEs3
Full Programme FeeS$3,375.00S$3,375.00S$3,375.00S$3,375.00S$3,375.00S$3,375.00
SkillsFuture Funding-(S$2,362.50)(S$2,362.50)(S$2,362.50)(S$2,362.50)(S$2,362.50)
Nett Programme FeeS$3,375.00S$1,012.50S$1,012.50S$1,012.50S$1,012.50S$1,012.50
7% GST on Nett
Programme Fee
S$236.25S$70.88S$70.88S$70.88S$70.88S$70.88
Total Nett Programme
Fee Payable, Incl. GST
S$3,611.25S$1,083.40S$1,083.40S$1,083.40S$1,083.40S$1,083.40
Less Additional Funding if
Eligible Under Various Scheme
--(S$675.00)(S$843.75)-(S$675.00)
Total Nett Programme Fee, Incl. GST,
after additional funding from the various funding schemes 
S$3,611.25S$1,083.40S$408.40S$239.65S$1,083.40S$408.40
1 Mid-Career Enhanced Subsidy - Singaporeans aged 40 and above may enjoy subsidies up to 90% of the programme fee.
2 Workfare Training Support (WTS) - Singaporeans aged 35 and above (13 years and above for persons With disabilities) and earn not more than S$2,000 per month, may enjoy subsidies up to 95% of the programme fee.
3 Enhanced Training Support for SMEs (ETSS) - SME-sponsored employees (Singaporean Citizens and PRs) may enjoy subsidies up to 90% of the programme fee. For more information, visit http://www.ssg.gov.sg/programmes-and-initiatives/training/enhanced-training-support-for-smes.html?_ga=2.154478072.1748789781.1519700056-512306731.1519700056

Application period: 1 October to 7 November 2018 

To apply for modules, visit https://myapplications.nus.edu.sg/ and search by Module Code